MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK/S-LINE; CUTTING ELECTRODE BIPO 22FR 12/30°

Model Number 8622133

Device Problems Material Fragmentation (1261); Arcing of Electrodes (2289)

Patient Problem Insufficient Information (4580)

Event Date 08/01/2023

Event Type  malfunction  

Event Description

Richard wolf (b)(6) has informed richard wolf gmbh of an issue regarding a cutting electrode bipo 22fr 12/30°, part id: 8622133, lot #21004154.According to the received information, the cutting electrode sparked and broke during a transurethral resection of bladder tumor (turbt) surgery.Because of this, the ceramic tip (part id: 8675322) on the inner shaft broke.The broken part of the ceramic tip was retrieved.There was a reported or time extension of 15 minutes.The scheduled procedure was completed.

• Brand Name: SHARK/S-LINE
• Type of Device: CUTTING ELECTRODE BIPO 22FR 12/30°
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 17869654
• MDR Text Key: 324915495
• Report Number: 9611102-2023-00055
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207018026
• UDI-Public: 04055207018026
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8622133
• Device Catalogue Number: 8622133
• Device Lot Number: 21004154
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/02/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1